Study on the neural mechanism of cognitive dysfunction in heart-qi deficiency syndrome

Registration number:

ITMCTR2024000246

Date of Last Refreshed on:

2024-08-16

Date of Registration:

2024-08-16

Registration Status:

Retrospective registration

Public title:

Study on the neural mechanism of cognitive dysfunction in heart-qi deficiency syndrome

English Acronym:

Scientific title:

Study on the neural mechanism of cognitive dysfunction in heart-qi deficiency syndrome

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

Bixiu Huo

Study leader:

Hongxiao Jia

Applicant telephone:

+86 132 6120 7917

Study leader's telephone:

+86 136 6133 8687

Applicant Fax:

Study leader's fax:

Applicant E-mail:

1678852049@qq.com

Study leader's E-mail:

jhxlj@ccmu.edu.cn

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

No.5 Ankang Hutong, Xicheng District, Beijing

Study leader's address:

No.5 Ankang Hutong, Xicheng District, Beijing

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Beijing Anding Hospital, Capital Medical University

Approved by ethic committee:

Approved No. of ethic committee:

2024科研第210号-2024248FS-2

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of Beijing Anding Hospital affiliated to Capital Medical University

Date of approved by ethic committee:

2024/7/16 0:00:00

Contact Name of the ethic committee:

Jingjin Jia

Contact Address of the ethic committee:

No.5 Ankang Hutong, Desheng Gate, Xicheng District, Beijing

Contact phone of the ethic committee:

010-58340320

Contact email of the ethic committee:

anding_lunli@sina.com

Primary sponsor:

Beijing Anding Hospital, Capital Medical University

Primary sponsor's address:

No.5 Ankang Hutong, Xicheng District, Beijing

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Institution
hospital:

Beijing Anding Hospital, Capital Medical University

Address:

No.5 Ankang Hutong, Xicheng District, Beijing

Source(s) of funding:

National Natural Science Foundation of China NO.82174311

Target disease:

Coronary heart disease

Target disease code:

Study type:

Observational study

Study design:

Cross-sectional

Study phase:

Pilot clinical trial

Objectives of Study:

Neuropsychological state assessment Scale and psychological experiment paradigm were used to evaluate and compare the cognitive function of heart-qi deficiency CHD patients and healthy people, and to explore the correlation and causality analysis of the changes in cognitive function, neuroimaging and bioelectrical activity of CHD patients.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

Inclusion criteria for case group: (1) Meet the diagnostic criteria of heart-qi deficiency syndrome; (2) Aged 18-65 years old, right-handed, junior high school education or above, simple Wechsler IQ test > 80, able to understand and cooperate with the questionnaire and examination involved in this study; (3) Meet the above diagnostic criteria for coronary heart disease, grade I to II heart function, and the condition is stable; (4) The total score of SCL-90 scale is < 160 points, and the number of positive items is < 43, and the score of any factor is not more than 2 points; Hamilton Anxiety Scale (HAMD) < 8 points, Hamilton Anxiety Scale (HAMA) < 7 points, Self-rating Anxiety Scale (SAS) < 50 points, Self-rating Depression Scale (SDS) < 50 points; (5) Voluntarily participate in clinical research and sign informed consent, and be able to understand and cooperate with this study. Control group inclusion criteria: (1) No organic and significant functional diseases, no sub-health symptoms; (2) Aged 18-65 years old, right-handed, junior high school education or above, simple Wechsler IQ test > 80, able to understand and cooperate with the questionnaire and examination involved in this study; (3) The total score of SCL-90 scale is < 160 points, and the number of positive items is < 43, and the score of any factor is not more than 2 points; Hamilton Anxiety Scale (HAMD) < 8 points, Hamilton Anxiety Scale (HAMA) < 7 points, Self-rating Anxiety Scale (SAS) < 50 points, Self-rating Depression Scale (SDS) < 50 points; (4) Voluntarily participate in clinical research and sign informed consent, and be able to understand and cooperate with this study.

Exclusion criteria:

Exclusion criteria for case groups: (1) There are contraindications to MRI scanning or poor blood pressure control, SBP≥140mmHg, DBP≥90mmHg; (2) Grade III to IV heart function, in the acute attack period, the condition is unstable; (3) Taking drugs other than those recommended by the guidelines for the treatment of heart failure and coronary heart disease; (4) Complicated with other cardiovascular diseases, such as atrial fibrillation, heart valvular disease, rheumatic heart disease, myocarditis, etc. (5) Those who have been diagnosed with mental diseases such as dementia, schizophrenia, depression and anxiety, have a history of major brain trauma, and have a history of major cerebrovascular accidents (cerebral hemorrhage, cerebral infarction); (6) In the past 2 weeks, there are serious infections, serious liver and kidney insufficiency, serious diseases of other systems except cardiovascular system, pregnant and lactating women, etc. Control group exclusion criteria: (1) Patients with contraindications for MRI examination; (2) Unable to understand and cooperate with the researcher.

Study execute time:

From 2024-05-31

To      2026-03-31

Recruiting time:

From 2024-07-16

To      2025-08-31

Interventions:

40

Group:

Control group

Sample size:

Intervention:

none

Intervention code:

40

Group:

Case group

Sample size:

Intervention:

none

Intervention code:

Total sample size : 80

Countries of recruitment
and research settings:

Country:

China

Province:

Beijing

City:

Institution/hospital:

Beijing Anding Hospital, Capital Medical University

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Hamilton Anxiety Scale

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

Stroop test

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

hs-TnT

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

NT-proBNP

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Pittsburgh Sleep Quality Index

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Symptom Checklist-90

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

MR-proANP

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Heart Qi deficiency syndrome accumulation table

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Zung’s Self-rating Depression Scale

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

Serum non-targeted metabolomics

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

WAIS-RC

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

hs-TnI

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

RBANS score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Heart rate variability

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Zung’s Self-rating Anxiety Scale

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

Hamilton Depression Scale

Type:

Additional indicator

Measure time point of outcome:

Measure method:

Outcome:

electroencephalogram

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
70
Max age years

Recruiting status:

Participant age:

Gender:

Both

Randomization Procedure (please state who generates the random number sequence and by what method):

Patients were naturally grouped according to whether or not they had coronary heart disease, without randomization

Blinding:

IPD sharing:

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

none

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF

Data Managemen Committee:

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above